MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 101; GENERATOR

Model Number 101

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2002

Event Type  malfunction  

Event Description

It was reported that the patient underwent vns explantation surgery due to lack of efficacy.The explanted products were received by the manufacturer.Generator product analysis was completed.The reported lack of efficacy could not be evaluated in the product analysis, or pa, lab however, the observed depleted battery could have been a contributing factor.It was observed that the supply current pulsing was out of specification during the post burn test.Analysis indicated that during manufacturing, the r35 resistor was not optimally chosen.A lower value resistor would have more suitably centered the currents within the limits.With r35 reselected in the pa lab, the device performed according to functional specification.The 2,868 o resistor was replace with a 2,671 o resistor and test specifications were met.The out of specification supply current pulsing could have potentially been a contributing factor to the end of service condition.However, the results of the battery longevity calculation indicated the eos condition was an expected event.The lead product analysis will not be reported as it was not relevant to the out of specification generator resistor.No additional relevant information has been received to date.

Manufacturer Narrative

Describe event or problem, corrected data: initial report inadvertently left out "a review of device history records revealed that a rework was performed due to the l2 chip.However, the generator passed quality control inspection prior to distribution.".

Event Description

A review of device history records revealed that a rework was performed due to the l2 chip.However, the generator passed quality control inspection prior to distribution.

• Brand Name: PULSE GEN MODEL 101
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7823794
• MDR Text Key: 118550605
• Report Number: 1644487-2018-01507
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2003
• Device Model Number: 101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 16 YR